의약품부작용보고시스템 데이터베이스를 이용한 fluconazole 및 itraconazole 관련 이상사례 분석
Real-world Adverse Events Associated with Fluconazole and Itraconazole: Analysis of Nationwide Data Using a Spontaneous Reporting System Database
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Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole anditraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmaciesnationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specifictype of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reportsof fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity ofcontraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole(46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR,1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women andin case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrenceof neurological AEs.
Abstract
Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole anditraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmaciesnationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specifictype of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reportsof fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity ofcontraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole(46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR,1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women andin case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrenceof neurological AEs.
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